Lung Tumor
Conditions
Keywords
VATS, thoracic surgery, acetaminophen, ofirmev, lung surgery, thoracoscopic, intravenous acetaminophen
Brief summary
We will study the efficacy of FDA approved intravenous (IV) acetaminophen (Ofirmev, © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Detailed description
We will study the efficacy of FDA approved intravenous (IV) acetaminophen (Ofirmev, © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Interventions
DRUGIV Acetaminophen
1000mg IV Ofirmev given every six hours for a total of four doses.
DRUGSaline Placebo
Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Sponsors
Mallinckrodt
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Any elective VATS patients with low probability of conversion to thoracotomy as determined by surgery. * Ages 18-99 * American Society of Anesthesiologists Physical Status I-III, hemodynamically stable * Male or female
Exclusion criteria
* Age less than 18. * Patient refusal * High probability of conversion to thoracotomy as determined by surgeon * Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional anesthesia). * Scheduled procedure of VATS Pleurodesis/decortication * History of Interstitial Lung Disease * Emergency case * Known allergy/adverse reaction to acetaminophen, morphine, or fentanyl * History of drug or alcohol abuse * Patients on preoperative analgesic therapy within one week of surgery * Contraindication to self administered morphine (unable to understand PCA) * Need for postoperative mechanical ventilation * Necessary major deviation for intraoperative study protocol as per the discretion of the intraoperative attending anesthesiologist * History of congestive heart failure, renal failure, liver failure * Pregnant or breastfeeding women * Weight less than 51 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Morphine Consumption (mg) | 24 hours | How much morphine the subject consumes in the first 24 hours after surgery (mg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of PCA Requests in First 24 Hours Post-Operation | 24 hours post-operation | The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation |
| VAS Pain Score 2 Hours Post Operation | 2 Hours Post Operation | 2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100). |
| VAS Pain Score 6 Hours Post-Operation | 6 Hours Post-Operation | 6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100). |
| VAS Score 24 Hours Post-Operation | 24 hours post-operation | 24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Placebo Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. | 8 |
| IV Acetaminophen Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Saline Placebo | IV Acetaminophen | Total |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 13.18 | 64.6 years STANDARD_DEVIATION 8.23 | 61.8 years STANDARD_DEVIATION 11.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 4 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Total Morphine Consumption (mg)
How much morphine the subject consumes in the first 24 hours after surgery (mg).
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | Total Morphine Consumption (mg) | 34.5 mg |
| IV Acetaminophen | Total Morphine Consumption (mg) | 44 mg |
Secondary
Total Number of PCA Requests in First 24 Hours Post-Operation
The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation
Time frame: 24 hours post-operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | Total Number of PCA Requests in First 24 Hours Post-Operation | 41 PCA requests |
| IV Acetaminophen | Total Number of PCA Requests in First 24 Hours Post-Operation | 43 PCA requests |
Secondary
VAS Pain Score 2 Hours Post Operation
2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100).
Time frame: 2 Hours Post Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | VAS Pain Score 2 Hours Post Operation | 75.5 mm |
| IV Acetaminophen | VAS Pain Score 2 Hours Post Operation | 49 mm |
Secondary
VAS Pain Score 6 Hours Post-Operation
6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100).
Time frame: 6 Hours Post-Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | VAS Pain Score 6 Hours Post-Operation | 68.5 mm |
| IV Acetaminophen | VAS Pain Score 6 Hours Post-Operation | 39 mm |
Secondary
VAS Score 24 Hours Post-Operation
24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100).
Time frame: 24 hours post-operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | VAS Score 24 Hours Post-Operation | 53 mm |
| IV Acetaminophen | VAS Score 24 Hours Post-Operation | 16.5 mm |